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首页> 外文期刊>Pediatric critical care medicine: a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies >How to ENHANCE our knowledge of activated protein C during pediatric sepsis trials: pediatric versus adult trials.
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How to ENHANCE our knowledge of activated protein C during pediatric sepsis trials: pediatric versus adult trials.

机译：如何在小儿败血症试验中增强我们对活化蛋白C的了解：小儿试验与成人试验。

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The rationale to do this study was to gather more safety and mortality information besides the already performed phase 1 study (EVAO) (9) and to prepare a phase 3 RCT with this drug in pediatric sepsis (RESOLVE). The investigators are well known in this field of research. The manuscript is clearly written, and both the disease and the drug are worth analyzing. However, with respect to the above-mentioned differences between pediatric and adult sepsis, some criticism is warranted here. The enrollment criteria for this study were not the same as those from the first pediatric open-label study (EVAO): an enrollment period of 12 hrs and three or more systemic inflammatory response syndrome criteria present, to 48 hrs and two or more systemic inflammatory response syndrome criteria in the ENHANCE trial.
机译：进行这项研究的理由是，除了已经进行的1期研究（EVAO）之外，还应收集更多的安全性和死亡率信息（9），并用这种药物在儿童败血症中进行3期RCT（RESOLVE）。研究人员在该研究领域中是众所周知的。手稿写得清楚，疾病和药物都值得分析。但是，关于小儿败血症和成人败血症之间的上述差异，在此值得批评。该研究的入选标准与第一项儿科开放标签研究（EVAO）的入选标准不同：入选时间为12小时，目前存在三个或更多全身性炎症反应综合征标准，至48小时和两个或多个全身性炎症ENHANCE试验中的反应综合征标准。

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